Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

140 results for "Harleco"
1–24 of 140
Search insights Median review: 23d Cleared: 100% Top manufacturer: Harleco Lead specialty: Chemistry
Cleared Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
K823147 · JIS
Harleco Diagnostics
Chemistry · 28d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852 · JIT
Harleco Diagnostics
Chemistry · 33d
Cleared Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
K822323 · CDW
Harleco Diagnostics
Chemistry · 30d
Cleared Jul 14, 1982
ULTRAZYME PLUS CK-I
K821883 · CGS
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS GPT
K821882 · CKA
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM CREA
K821881 · CGX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRA CHEM ALB
K821880 · CIX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T.P.
K821879 · CEX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS LDH
K821878 · CFJ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS HBD
K821877 · JMK
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T-BILI
K821873 · CIG
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM URIC ACID AIDH
K821872 · CDO
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS 2GT
K821871 · JPZ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876 · CIT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875 · CDT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM PHOS
K821874 · CEO
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870 · CJE
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869 · JFJ
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868 · CFR
Harleco Diagnostics
Chemistry · 13d
Cleared Jul 06, 1982
ULTRACHEM GLUC-DH
K821867 · LFR
Harleco Diagnostics
Chemistry · 11d
Cleared Feb 12, 1982
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233 · JQB
Harleco
Chemistry · 15d
Cleared Dec 31, 1981
ULTRACHEM GLUC-DH
K813427 · LFR
Harleco
Chemistry · 24d
Cleared Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
K813044 · CIX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CREA ITEM #64972
K813043 · CGX
Harleco
Chemistry · 13d